Detection of Eating Disorders in Pregnant Women (PREGN'ED)
Primary Purpose
Eating Disorders, Pregnancy Related
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Administration of the SCOFF-F and EDE-Q questionnaires
Sponsored by
About this trial
This is an interventional diagnostic trial for Eating Disorders
Eligibility Criteria
Inclusion Criteria: Adult pregnant woman Woman with current diagnosed Eating Disorders or without Eating Disorders Having a good command of the French language Having given their consent for their participation in the research Exclusion Criteria: Underage pregnant woman Woman who does not have a good command of the French language. Woman with past Eating Disorders
Sites / Locations
- Centre Hospitalier Henri LaboritRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group of pregnant women with eating disorder
Group of pregnant women with no eating disorder
Arm Description
Outcomes
Primary Outcome Measures
Specific Eating Disorders items in pregnant women
A discriminant factor analysis will be used to study whether there are elements that can distinguish women with an Eating Disorders from those who do not have one during pregnancy.
Secondary Outcome Measures
Full Information
NCT ID
NCT05885971
First Posted
May 23, 2023
Last Updated
August 18, 2023
Sponsor
Centre Hospitalier Henri Laborit
1. Study Identification
Unique Protocol Identification Number
NCT05885971
Brief Title
Detection of Eating Disorders in Pregnant Women
Acronym
PREGN'ED
Official Title
Detection of Eating Disorders in Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Actual)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Henri Laborit
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Eating disorders (ED) are insufficiently detected and belatedly or not treated during pregnancy.
There are many screening questionnaires for eating disorders in the literature, but we note the absence of a specific and validated tool for their screening during pregnancy, which would make it possible to differentiate maternal dietary concerns related to pregnancy from symptoms linked to a proven eating disorder.
The main objective of the study is to evaluate which items of the Sick Control One stone Fat Food (SCOFF-F) and Eating disorders examination questionnaire (EDE-Q) questionnaires could be specific to an ED during pregnancy and not related to the simple state of pregnancy, by comparing the answers of pregnant women, for whom the diagnosis of ED has been made, to those of pregnant women without an ED.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Pregnancy Related
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group of pregnant women with eating disorder
Arm Type
Other
Arm Title
Group of pregnant women with no eating disorder
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Administration of the SCOFF-F and EDE-Q questionnaires
Intervention Description
The participants will answer to the SCOFF-F and EDE-Q questionnaires as well as socio-demographic questions
Primary Outcome Measure Information:
Title
Specific Eating Disorders items in pregnant women
Description
A discriminant factor analysis will be used to study whether there are elements that can distinguish women with an Eating Disorders from those who do not have one during pregnancy.
Time Frame
36 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult pregnant woman
Woman with current diagnosed Eating Disorders or without Eating Disorders
Having a good command of the French language
Having given their consent for their participation in the research
Exclusion Criteria:
Underage pregnant woman
Woman who does not have a good command of the French language.
Woman with past Eating Disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte XAVIER-DAVID
Phone
(0)5 49 52 34 93
Ext
+33
Email
charlotte.xavier-david@ch-poitiers.fr
Facility Information:
Facility Name
Centre Hospitalier Henri Laborit
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte XAVIER-DAVID, MD
12. IPD Sharing Statement
Learn more about this trial
Detection of Eating Disorders in Pregnant Women
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